CliniMACS PBS/EDTA Buffer 1L

Primary DI
04049934004672
Brand
CliniMACS PBS/EDTA Buffer 1L
Company
Miltenyi Biotec GmbH
Model
70026
Catalog number
700-25
Device description
CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 R
Published
2016-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)Unknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BH1100180

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BH1100180

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049934004672PrimaryGS10
04049934001666Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049934004672040499340046724049934004672
04049934001666040499340016664049934001666

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic cell separation system buffered saline solutionA sterile buffered aqueous salt solution that is a component of a magnetic cell separation system intended to be used during the magnetic separation of target cell types or subpopulations from heterogeneous human cell preparations. The device is intended for the priming of the separation system as well as the washing and elution of separated cells and to prevent cell aggregation and adherence. It is supplied in a container (e.g., polypropylene bag) and is not for direct intravenous (IV) infusion. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-810-3135Regulatory_Affairs_USA@milteny

Regulatory Flags#

DUNS number
327036034
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049934004674CliniMACS PBS/EDTA Buffer 1LMiltenyi Biotec B.V. & Co. KGOVG2016-07-22
04049934004834CliniMACS Tubing Set TSMiltenyi Biotec B.V. & Co. KGOVG2016-07-22
04049934004636CliniMACS Plus InstrumentMiltenyi Biotec B.V. & Co. KGOVG2015-03-26
04049934004827CliniMACS CD34 ReagentMiltenyi Biotec B.V. & Co. KGOVG2015-03-26
04049934004841CliniMACS Tubing Set LSMiltenyi Biotec B.V. & Co. KGOVG2015-03-26